Kornimate/medical-research-clean huggingface dataset:
intensive ambulance-delivered blood pressure reduction in hyper-acute stroke trial

Conditions: Stroke, Acute; Cerebrovascular Disorders

Summary: a multicentre, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (probe) study to assess the effects of hyperacute intensive blood pressure (bp) lowering initiated in ambulance setting on (i) functional outcome in patients with acute stroke (ii) safety in patients with confirmed acute stroke and other conditions that were initially suspected as acute stroke (i.e. stroke mimic).

as an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (probe) study. interact4 aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mrs, the safety in all randomised patients; reperfusion treatment (thrombolysis and/or thrombectomy) related symptomatic ich (sich, according to standard definitions), infarct size, the time to and overall rate of reperfusion treatment in ais patients; hematoma volume and early expansion in ich.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. acute syndrome that is due to presumed acute stroke, defined as fast（face, arm, speech, time） scores of ≥2 with an arm motor deficit and time ≤2 hours from last seen well; 3. systolic bp ≥150 4. able to provide brief informed consent (if a waver of consent is not approved by the ethics committee) exclusion criteria: 1. coma - no response to tactile stimuli or verbal stimuli; 2. severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia,severe heart failure,pre-stroke disability\[needed help\]); 3. history of epilepsy or seizure at onset; 4. history of recent head injury (\<7 days); 5. hypoglycemia(glucose\<2.8mmol/l)

Keywords: stroke blood pressure control hypertension clinical trial ambulances
cardiac-ct in the treatment of acute chest pain

Conditions: Ischemic Heart Disease

Summary: objectives the catch trial (cardiac ct in the treatment of acute chest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (mdct) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional functional-based testing strategy. methods: consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal electrocardiogram and biomarkers were randomized to evaluation with 320-mdct coronary angiography (ct-guided group) or with standard bicycle exercise test and/or myocardial perfusion imaging - mpi (control group). after one year, patients will be followed-up, with registration of clinical endpoints such as cardiac death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.


Eligibility criteria:
inclusion criteria: * admittance because of chest pain * non- or non-diagnostic ecg-changes. * normal biomarkers for ischemia (troponins) * chest x-ray without pathological findings associated with chest pain. exclusion criteria: * women of childbearing age, or \> 40 years and using approved contraception. * claustrophobia * patients with geographical residence, that complicates follow-up * patients with mental or physical conditions that impede follow-up * increase in troponins * new diagnostic ecg changes with st-segment elevation or depression greater than 1mm or t-yew inversion\> 4 mm in\> 2 anatomically connected derivations. * allergy to iodinated contrast agents * serum creatinine greater than 130 mg/l * abnormal chest x-ray or blood tests hospitalization as assessed as the main cause of the patient's pain problem.

Keywords: cardiac ct ischemic heat disease stress test
effects of fiber on satiety

Conditions: Obesity

Summary: the effects of a dietary fiber on hunger and food intake will be tested in men and women. participants will receive fiber as part of a breakfast meal on two occasions. on another occasion, participants will receive the same breakfast, without added fiber. their feelings of hunger and fullness will be measured over the day. they will be offered lunch, dinner and an evening snack and how much they eat will be recorded. it is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.


Eligibility criteria:
inclusion criteria: * normal-weight adults exclusion criteria: * eating disorders, * on medications that affect food intake, * pregnant or lactating, * non-breakfast eaters

Keywords: food intake, satiety, fiber
corneal topographic changes in different grades of osa

Conditions: Corneal Ectasia

Summary: corneal topographic parameters in different degrees of obstructive sleep apnea

obstructive sleep apnea (osa) syndrome is a disease characterized by recurrent total or partial upper airway collapse during sleep, interrupting or reducing the airflow, and after ward resulting in temporary awakening which causes restoration of flow of the upper airway. these intermittent complete (apnea) or partial (hypopnea) respiratory cessations decrease blood oxygen levels (hypoxia). upper airway stenosis causes hypoxemia and hypercapnia, which can lead to multiple organ dysfunction and is associated with systemic diseases, such as hypertension, diabetes, and coronary arteriosclerosis, and changes in the eyes include floppy eyelid syndrome, keratoconus, and glaucoma. the prevalence of osa is between 2% and 10% in females and 4-20% in males and obesity is a major risk factor for the development of osa. with all the adverse effects associated with osa, its secondary effects cause several ocular complications. previous studies have shown that osa is associated with increased risks of several vision-threatening and nonthreatening ocular disorders, including senile cataracts, normal-tension glaucoma, retinal ischemia, conjunctival hyperemia, and dry eye. several contributory mechanisms to the ocular complications of osa have been reported, including intermittent hypoxia, oxidative stress, systemic inflammatory responses (such as interleukin-6 (il-6), il-8, tumor necrosis factor-alpha (tnf-α), c-reactive protein (crp), matrix metalloproteinase 9 (mmp-9), vascular cell adhesion molecule (vcam), intercellular adhesion molecule (icam), selectins), sympathetic system overaction, damage effects of endothelin-1, and disruption of the blood-retinal barrier (brb) (6-8). there are limited publications that manipulate the corneal topographic parameters in different degrees of osa, especially in the egyptian population.

Eligibility criteria:
inclusion criteria: * patients with diagnosed osa exclusion criteria: * any corneal scars, previous ocular surgeries, patients with keratoconus
first human dose trial of nnc0195-0092 (somapacitan) in healthy subjects

Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of nnc0195-0092 (somapacitan) compared to placebo in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking male subjects * bmi (body mass index) between 18.0 and 28.0 kg/m\^2, both incl. * body weight 50 to 100 kg, both incl. exclusion criteria: * strenuous exercise within 4 days prior to dosing * receipt of any investigational medicinal product within 3 months prior to randomisation
examine the possible association of hepatic cyp3a activity and the susceptibility to femur head necrosis

Conditions: Femur Head Necrosis

Summary: the purpose of the present study was to examine the possible association of hepatic cyp3a activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

femur head necrosis is one of the major side effects of corticosteroid therapy. since corticosteroids are metabolized by hepatic cytochrome p-450 (cyp) 3a, a low endogenous activity of this enzyme may contribute to the pathogenesis of onfh. the purpose of the present study was to examine the possible association of hepatic cyp3a activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of avascular necrosis of the femur exclusion criteria: * old age (\> 70 years) * severe hepatic or renal dysfunction * heart disease * current use of known cyp3a-inducing or -inhibiting drugs * morbid obesity

Keywords: femur head necrosis cyp3a
second-line irinotecan or gefitinib in docetaxel pretreated nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: to determine whether in docetaxel pretreated advanced nsclc patients with favorable clinical parameter(s) gefitinib can produce different outcomes from patients without favorable clinical parameter treated with irinotecan.

it has been suggested that some clinical parameters, including women, no smoking history and a histologic diagnosis of adenocarcinoma, are associated with favorable outcomes of gefitinib therapy. we will conduct a phase ii study in docetaxel pretreated advanced nsclc patients treated with gefitinib or irinotecan according to these clinical parameters in order to determine whether in patients with favorable clinical parameter(s) gefitinib will produce difference outcomes from patients without favorable clinical parameter treated with irinotecan.

Eligibility criteria:
inclusion criteria: * aged 75 years or less * histologically or cytologically confirmed non-small cell lung cancer * advanced, metastatic or recurrent * ecog performance status 0 to 2 * one prior palliative chemotherapy including docetaxel * measurable or evaluable indicator lesion(s) * normal marrow, hepatic and renal function * provision of written informed consent exclusion criteria: * active infection and/or severe comorbidities * pregnant or breastfed women * active cns metastasis * active bleeding in gi tract or elsewhere
mechanisms of myocardial injury and ischemia in patients with rapid atrial fibrillation

Conditions: Atrial Fibrillation (AF)

Summary: the goal of this observational study is to better understand the role of measuring troponin (a protein measured by a blood test) and coronary imaging in patients presenting with rapid atrial fibrillation (af) the main questions this study aims to answer are: 1. are patients with a fast, irregular heartbeat (rapid af) and damage to the heart (myocardial injury) more likely than those without damage to the heart to have blocked heart arteries (obstructive coronary artery disease) 2. are patients with a fast, irregular heartbeat (rapid af) and damage to the heart (myocardial injury) with further evidence that their heart hasn't been getting enough oxygen (myocardial ischemia) more likely to have imaging evidence of myocardial infarction than those without myocardial ischemia to do this, we will measure troponin in patients with rapid af and then carry out further investigations of the heart (electrocardiogram, echocardiogram, ct scan and cardiac mri)


Eligibility criteria:
inclusion criteria: 1. age 18 years and over 2. primary presentation with symptoms related to atrial fibrillation 3. atrial fibrillation with a ventricular rate \>100 bpm on a 12-lead electrocardiogram 4. able to provide informed consent exclusion criteria 1. previous myocardial infarction 2. previous coronary revascularisation procedure 3. patients in renal failure (egfr \<30ml/min/1.73m2) or major allergy to contrast media 4. pregnancy or breast feeding 5. deemed unsuitable for participation in the study by the attending clinician 6. previous enrolment in the trial

Keywords: atrial fibrillation cardiology emergency medicine myocardial infarction myocardial ischemia coronary artery disease
effects of exposed to antipsychotics throughout pregnancy on infants development: a prospective study

Conditions: Schizophrenia

Summary: the primary aim of this prospective study is to evaluate the effect of antipsychotics on infant development especially neurobehavioral development which evaluated by the bayley-iii when mothers are treated with antipsychotics throughout their pregnancy.

the neurodevelopmental effect of antipsychotics on fetus has always been a major concern for women who need antipsychotic treatments and are in their reproductive years. the fear of harmful effects from antipsychotic on fetus and unplanned pregnancy commonly causes non-adherence to treatments. even for those who are willing to maintain their antipsychotic treatments during pregnancy, the fear of potential harmful effects from antipsychotic on fetus can still exist. it is well known that non-adherence to antipsychotic treatments in patients with schizophrenia can cause most to relapse and poor treatment response. the consequences of relapse not only increase personal suffering, but also increase family and societal burden.clearly, it is important to evaluate the safety of antipsychotics during pregnancy. however, up to now, most information about antipsychotics on reproductive safety and the effects on infant development come from case reports, case series, and retrospective studies.so the study was to investigate the developmental effects of antipsychotics on infants who were exposed to as fetus.

Eligibility criteria:
inclusion criteria: * newborns * exposed to antipsychotic as fetus * no exposed to antipsychotic exclusion criteria: * malformation * liver dysfunction * renal dysfunction * cardiovascular diseases

Keywords: antipsychotic schizophrenia infant development
a feasibility study of virtopsy with tissue sampling in besancon university hospital

Conditions: Stillbirth and Fetal Death; Termination of Pregnancy; Neonatal Death

Summary: the aim of this project is to assess the feasibility of a new local post mortem procedure at besançon university hospital : virtopsy+, magnetic resonance (mr) imaging with tissue sampling of the fetus and newborns.

minimally invasive autopsy is an alternative for conventional autopsy including post mortem magnetic resonance (mr) imaging and tissues samplings. because of the raise of parental refusal of autopsy, we intend to assess the local feasibility of a minimally invasive autopsy approach using post mortem mr imaging of fetuses and newborns in order to detect the major pathological abnormalities and/or to determinate the cause of death.

Eligibility criteria:
inclusion criteria: * stillbirth and fetal deaths over 21 weeks of gestation * termination of pregnancy over 21 weeks of gestation * neonatal death * patient having read the letter of information and signed the consent. exclusion criteria: * legal incapacity * limited ability to consent * lack of parental consent

Keywords: post mortem magnetic resonance imaging stillbirth fetal death neonatal death minimally invasive autopsy tissue samplings
double the dose of clopidogrel or switch to prasugrel to antagonize proton pump inhibitor interaction.

Conditions: Anti Platelet Effects

Summary: this study will establish the optimal therapeutic strategy for patients with a coronary artery disease (cad) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with p2y12 antagonist and a ppi for treatment/prevention of gi ulceration.


Eligibility criteria:
inclusion criteria : * patient with stable coronary artery disease (\< 3 months) treated with clopidogrel (75mg/d) * between 18 and 75 years of age * body mass index between 18 and 30 kg/m2 and body weight not less than 60 kg * no major bleeding according to isth definition * subjects who signed an informed consent document * subjects who signed a separate pharmacogenomic informed consent document * subjects registered to the french national welfare system exclusion criteria: * personal or family history of coagulation or bleeding disorders * use of known inhibitors or inducers of cyp2c19 and cyp3a including grape fruit juice intake * known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles, * known hypersensitivity to clopidogrel / prasugrel * anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion * any formal indication to maintain ppi treatment * ppi within 15 days before inclusion in the study * active pathology with 10 days before inclusion * prior history of stent thrombosis * prior history of stroke * employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
biospecimen and medical data collection and tumor biopsy in creating research tissue registry in patients with inflammatory or invasive breast cancer

Conditions: Inflammatory Breast Carcinoma; Invasive Breast Carcinoma; Second Primary Malignant Neoplasm

Summary: this trial studies the biospecimen and medical data collection in creating a research tissue registry in patients with inflammatory or invasive breast cancer. collecting medical data and storing samples of blood, tissue, and stool from patients with inflammatory breast cancer to study in the laboratory may help doctors find better ways to treat and study inflammatory breast cancer in the future.

primary objectives: i. to prospectively collect tissue (including primary inflammatory breast cancer \[ibc\], ipsilateral nodal metastasis and/or distant metastasis \[if applicable\] obtained prior to primary systemic therapy and mastectomy/axillary dissection), serum, plasma, whole blood, clinical, and imaging data from patients with recently diagnosed inflammatory breast cancer (ibc), or highly suspicious for ibc, who have not received systemic therapy. ii. to collect paraffin tissue blocks or unstained slides (including primary, ipsilateral nodal metastasis and/or distant metastasis \[if applicable\] obtained prior to primary systemic therapy), mastectomy/axillary dissection tissue, serum, plasma, whole blood, clinical, and imaging data (if available) from patients with previously diagnosed inflammatory breast cancer (ibc), who have been treated or partially treated, but have not had mastectomy and are seeking further treatment in the ibc clinic at m. d. anderson or participating cancer network sites. iii. to collect oral swab, skin and stool bacterial culture swab for microbiome analysis to compare patients with specific breast cancer subtype to report changes in flora during the course of treatment and correlated to toxicity. outline: patients complete questionnaires and participate in interview over 30 minutes. patients also undergo collection of medical data and blood, tissue, and stool samples.

Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of primary inflammatory breast cancer (ibc), second primary ibc, or highly suspicious for ibc (md anderson patients only). * histological diagnosis of invasive breast cancer, or highly suspicious for ibc (md anderson patients only) but pending breast cancer diagnosis. * be either newly diagnosed, or highly suspicious for ibc (md anderson patients only) \[cohort i\] or have paraffin blocks or up to 20 unstained slides of each representative block(s) from the time of initial diagnosis of ibc(i.e. core biopsy and punch biopsy) and/or from mastectomy (cohort ii-md anderson patients only) * age \> 18 years * able to provide informed consent exclusion criteria:
quality control of ventral hernia surgery by prospective registration

Conditions: Ventral Incisional Hernia

Summary: quality control of ventral hernia surgery in 21 belgian hospitals by prospective registration in close collaboration with the danish hernia database.


Eligibility criteria:
inclusion criteria * consecutively all patients with an elective or emergency repair of every ventral/incisional hernia (including parastomal hernia) * male and female * 18 years or older * operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of one of the 18 participating belgian hospitals, but by specific surgeons) * elective and emergency surgery * signed informed consent form exclusion criteria * younger than 18 years * not operated or supervised by participating surgeon * pregnant at inclusion in the registry * no signed informed consent form
transplantation of hematopoietic cells in children with severe combined immunodeficiency syndrome

Conditions: Severe Combined Immunodeficiency

Summary: treatment for severe combined immunodeficiency (scid) is a medical emergency. a stem cell transplant (immature blood cells that can make other blood cells) from a (msd) matched sibling donor (brother or sister who is a "match" for your child's immune (hla) type), usually results in complete correction of immune function. however, most patients lack a matched sibling donor, requiring the use of an alternate donor source. transplantation of cells from haploidentical family donors (typically parents) has resulted in immune system correction in the majority of scid individuals. however, only 65-80% of patients survive greater than one year after this procedure. failure results from life-threatening infections, graft versus host disease (gvhd) or post-transplant treatment-related effects. also, for patients that survive beyond one year, b-cell (type of blood cell that fights infection) and natural killer cell function (cell that attacks infections and cancer cells) frequently fail to work, resulting in the need for long-term treatment with intravenous gamma-globulin (ivig). in this study, in an effort to restore the overall cell function in patients with scid, researchers will use a highly purified cd133+ hematopoietic cell graft (stem cell transplant without many mature donor white cells, called t-cells) obtained via use of the miltenyi clinimacs device, a device not fda approved.


Eligibility criteria:
inclusion criteria: * patient with confirmed severe combined immunodeficiency * two years of age or younger * a suitable matched sibling donor is not available exclusion criteria: * an available matched sibling donor or a confirmed matched unrelated donor * patients with digeorge syndrome, zap70, mhc class ii deficiency, or cartilage-hair hypoplasia * patients with a lansky performance score of less than 10, evidence of hiv or a congenital rubella infection or a documented neoplasm * patients in whom it is not possible to perform a peripheral blood cell harvest on a haploidentical family member

Keywords: severe combined immunodeficiency transplantation haploidentical